For Patients

Actimmune (interferon gamma 1 b) is a specific interferon used to prevent infections in people with a condition called Chronic Granulomatous Disease. It is also used to treat a congenital bone disorder called osteopetrosis. It is made from human proteins. Common side effects include injection site reactions (pain/swelling/redness), diarrhea, upset stomach, nausea, or vomiting. Flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches may occur, especially when you first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use.

The recommended dosage of Actimmune for the treatment of patients with Chronic Granulomatous Disease and severe, malignant osteopetrosis is 50 mcg/m2 (1 million IU/m2) for patients whose body surface area is greater than 0.5 m2 and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m2. Other drugs may affect Actimmune. Tell your doctor all medications and supplements you use. Actimmune is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Actimmune (interferon gamma 1 b) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Injection site reactions (pain/swelling/redness), diarrhea, upset stomach, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches may occur, especially when you first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use. You can reduce these side effects by injecting this medicine at bedtime and using a fever reducer/pain reliever such as acetaminophen before or after each dose. Consult your doctor or pharmacist for more information.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes, pain/redness/swelling of the arms/legs, calf pain/swelling that is warm to the touch, coughing up blood.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

The following data on adverse reactions are based on the subcutaneous administration
of ACTIMMUNE (interferon gamma 1 b) at a dose of 50 mcg/m2, three times weekly, in patients
with Chronic Granulomatous Disease (CGD) during an investigational trial in
the United States and . Europe.

The most common adverse events observed in patients with CGD are shown in the following table:

Similar safety data were observed in 34 patients with severe malignant osteopetrosis.

ACTIMMUNE (interferon gamma 1 b) has also been evaluated in additional disease states in studies in
which patients have generally received higher doses ( > 100 mcg/m2/three
times weekly) administered by intramuscular or subcutaneous injection, or intravenous
infusion. All of the previously described adverse reactions which occurred in
patients with Chronic Granulomatous Disease have also been observed in patients
receiving higher doses. Adverse reactions not observed in patients with Chronic
Granulomatous Disease but reported in patients receiving ACTIMMUNE (interferon gamma 1 b) (Interferon
gamma-1b) in other studies include:

Post-Marketing Experience

Children with CGD less than 3 years of age

Data on the safety and activity of ACTIMMUNE (interferon gamma 1 b) in 37 patients under the age of 3 years was pooled from four uncontrolled post-marketing studies. The rate of serious infections per patient-year in this uncontrolled group was similar to the rate observed in the ACTIMMUNE (interferon gamma 1 b) treatment groups in controlled trials. Developmental parameters (height, weight and endocrine maturation) for this uncontrolled group conformed to national normative scales before and during ACTIMMUNE (interferon gamma 1 b) therapy.

In 6 of the 10 patients receiving ACTIMMUNE (interferon gamma 1 b) therapy before age one year 2-fold
to 25- fold elevations from baseline of AST and/or ALT were observed. These
elevations occurred as early as 7 days after starting treatment. Treatment with
ACTIMMUNE (interferon gamma 1 b) was interrupted in all 6 of these patients and was restarted at a
reduced dosage in 4. Liver transaminase values returned to baseline in all patients
and transaminase elevation recurred in one patient upon ACTIMMUNE (interferon gamma 1 b) rechallenge.
An 11-fold alkaline phosphatase elevation and hypokalemia in one patient and
neutropenia (ANC= 525 cells/mm3) in another patient resolved with
interruption of ACTIMMUNE (interferon gamma 1 b) treatment and did not recur with rechallenge.